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BSI - BS EN 61010-2-040 - TC

Tracked Changes (Redline) - Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-040: Particular requirements for sterilizers and washer disinfectors used to treat medical materials

active, Most Current
Organization: BSI
Publication Date: 25 February 2020
Status: active
Page Count: 94
ICS Code (Electrical and electronic testing): 19.080
ICS Code (Chemical laboratories. Laboratory equipment): 71.040.10
ICS Code (Sterilizing equipment): 11.080.10
scope:

Equipment included in scope

This part of IEC 61010 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical, veterinary, pharmaceutical and laboratory fields, when used under the environmental conditions of 1.4.

Examples of such equipment include the following:

a) sterilizers and disinfectors using steam, and/or hot water as the sterilant;

b) sterilizers and disinfectors using toxic gas, toxic aerosol or toxic vapour as the sterilant;

c) sterilizers and disinfectors using hot air or hot inert gas as the sterilant; and

d) washer disinfectors.

Equipment excluded from scope

NOTE IEC 60601-1 defines medical electrical equipment as follows:

Electrical equipment, provided with not more than one connection to a particular supply MAINS and intended by its manufacturer to be used in the diagnosis, treatment, or monitoring of a patient; and that makes physical or electrical contact with the patient or transfers energy to or from the patient or detects such energy transfer to or from the patient.

This part of IEC 61010 does not apply to the following types of equipment:

aa) equipment for use in hazardous atmospheres (see IEC 60079) but does apply to an atmosphere created inside equipment by a flammable sterilizing agent (see 13.0);

bb) laboratory equipment for the heating of materials for other purposes than sterilization or disinfection (see IEC 61010-2-010);

cc) laundry equipment (see IEC 60335-2-4, IEC 60335-2-7, IEC 60335-2-11, and ISO 10472), unless designed for disinfecting medical materials;

dd) dishwashers (see IEC 60335-2-5 and IEC 60335-2-58).

Aspects included in scope

g) liberated gases (including the non-intentional escape of toxic gas), pathogenic substances, explosion and implosion (see Clause 13).

Aspects excluded from scope

aa) special requirements for protection against chemical and high-risk micro-biological HAZARDS associated with the LOAD;

bb) general requirements for the design of calorifiers, shell boilers and PRESSURE VESSELS.

NOTE National and other regulations or codes apply for the safety of calorifiers, shell boilers and PRESSURE VESSELS (see 14.101).

Document History

BS EN 61010-2-040 - TC
February 25, 2020
Tracked Changes (Redline) - Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-040: Particular requirements for sterilizers and washer disinfectors used to treat medical materials
Equipment included in scope This part of IEC 61010 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical,...

References

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